Job Title
Regulatory Consultant (CMC/ EU Market Experience)
About Syneos Health
Syneos Health® is a leading, fully integrated biopharmaceutical solutions organization built to accelerate customer success. Our model places both customers and patients at the center of everything we do. With more than 29,000 employees across 110 countries, we continuously innovate to simplify processes, deliver therapies faster, and change lives.
Work Here Matters Everywhere.
Why Syneos Health
Career development and progression opportunities.
Supportive and engaged line management.
Technical and therapeutic area training.
Peer recognition and total rewards program.
A Total Self culture that allows you to authentically be yourself.
A global, inclusive environment built on diversity of thought, background, and perspective.
Position Summary
Provide regulatory and technical support for assigned CMC post-approval variations, renewals, annual reports, legal entity name changes (LENC), and other lifecycle maintenance activities.
Experience in product development projects—including preparation of regulatory submissions and supporting clients/project teams—is highly desirable.
Key Responsibilities
Regulatory Documentation & Submissions
Author and review Module 3 CMC sections for post-approval variations, renewals, annual reports, LENC, and other lifecycle activities.
Assess regulatory impact of changes raised via change control and develop appropriate submission strategies.
Conduct research of existing product data to meet regional/global regulatory requirements (e.g., gap analyses, development plans).
Contribute to or prepare administrative and technical components of submissions (IND, NDA, MAA, PMA, CTD, electronic submissions).
Prepare briefing packages for regulatory agency meetings and support agency interactions.
Project Management & Support
Manage day-to-day regulatory activities for assigned projects within agreed timelines, budgets, and scope.
Serve as regulatory support on multidisciplinary project teams throughout the product lifecycle.
Provide subject matter expertise, troubleshooting support, and propose solutions to project-related issues.
Prepare cost estimates for regulatory services and support business development activities.
Participate in client meetings to discuss proposals and project status.
Compliance & Quality
Ensure compliance with global regulatory requirements, company policies, and processes.
Prepare training materials, share best practices, and participate in audits (internal/external).
Contribute to SOP creation/maintenance and other process documentation.
Maintain personal training records (Syneos Health or client-related).
Team Contribution
Provide oversight and guidance to team members in execution of project responsibilities.
Identify when additional line support or guidance is required.
Collaborate on internal cross-functional initiatives.
Qualification Requirements
Education: MS, M.Pharm, or PhD in a science-related field (or equivalent regulatory/scientific experience).
Experience:
5+ years total work experience; 4+ years in Regulatory Affairs.
Mandatory EU market experience; experience in GCC and MEA markets preferred.
Proven track record in regulatory submissions (post-approval CMC variations, IND, NDA, MAA, PMA, CTD, eCTD).
Skills:
Excellent written and verbal communication skills in English.
Strong customer service and interpersonal skills.
Solid quality management, analytical, and problem-solving skills.
Ability to work independently and manage multiple concurrent projects.
Proficiency in Microsoft Office applications.
Experience with Veeva RIMS, TrackWise, or similar RIMS systems preferred.
Adaptability, initiative, and attention to detail.
Additional Information
Responsibilities listed are not exhaustive; additional tasks may be assigned.
Equivalent experience, education, or skills may be considered.
This job description complies with global employment legislation, including the EU Equality Directive and ADA (Americans with Disabilities Act) requirements.
About Our Work
Partnered on 94% of FDA-approved drugs in the past 5 years.
Worked on 95% of EMA-authorized products.
Conducted 200+ studies across 73,000 sites with over 675,000 patients.
At Syneos Health, we encourage applicants whose experiences may not align perfectly but who bring transferable skills and passion to make a difference.
Learn more: www.syneoshealth.com
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